Industry makes fake drug recommendations
drug supply, an industry group has submitted a report to the Food
and Drug Administration (FDA) as a commentary on policy issues
surrounding prescription drug counterfeiting, and offering
recommendations on anti-counterfeiting measures.
The report, prepared by the National Association of Chain Drug Stores (NACDS) calls for a national classification system to be set up to rank pharmaceuticals according to the level of risk from counterfeiting on patient safety. This would prioritise and focus resources on the drugs most vulnerable to counterfeiting.
It also recommends a track and trace system, similar to imported food regulations already in place in the US. This would implement a 'one-step-back, one-step-forward' record-keeping system, ensuring drug authenticity for very high risk drugs.
Under this system, every member of the supply channel would track the immediate source and recipient of drug products. The NACDS makes specific reference to Radio Frequency Identification (RFID) as a suitable technology to use in this process, as it would allow tracking of all prescription drugs throughout the drug distribution channel.
Meanwhile, the FDA should provide guidance to the industry on building in anti-counterfeiting measures into packaging, particularly for high-risk drugs, says the trade body. Measures could include colour printing technologies, barcodes and holograms, etc.
However, it is notable that the US has been somewhat slower to require the adoption of blister packaging than in Europe, which presents an extra obstacle to counterfeiters.
States and the FDA should also implement more stringent licensing requirements on wholesalers and drug re-packagers, including tougher penalties and frequent inspections for all distributors in the prescription drug channel. A breakdown in supply chain monitoring was at the heart of the problems with fake Pfizer's cholesterol-lowering drug Lipitor (atorvastatin) in the US earlier this year.
The FDA formed an Anti-Counterfeiting Task Force in July to tackle the counterfeit drug problem. The Task Force released an interim report in October and expects to have a final report completed in early 2004.
The agency insists that the problem is still small, but growing from a handful of cases a year in the 1990s to more than 20 in 2003. And the problem is particularly difficult to scale in global terms; the International Federation of Pharmaceutical Manufacturers Association (IFPMA) in Geneva estimates that 2 per cent of the drugs sold each year are counterfeit, while the World Heath Organization (WHO) estimates that 5 to 8 per cent of the drugs sold worldwide are fake.
